MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK HI-FLEX TIBIAL INSERT, SZ 2, 9MM; SEE H10

Model Number	244-22-09
Medical Device Problem Codes	Naturally Worn (2988); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Synovitis (2094); Osteolysis (2377); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/06/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via legal documentation that a patient had a right total knee arthroplasty revision on (b)(6) 2019 and then approximately 3 years later had a second surgical revision on (b)(6) 2022.The patient was revised to a competitor¿s devices.Second revision operative report on (b)(6) 2022.Preliminary diagnosis: 1.Recall right knee implant 2.Osteolysis right knee.Indication: patient began developing increasing pain.Postoperative diagnosis: loosening/debonding right femoral implant right knee.Procedure: the femur was noted to be well fixed.Because of mri imaging findings a decision was made to remove the femur.The tibia was noted to be well fixed.Devices were then implanted.A sterile compressive dressing was applied.The patient was awakened and transferred to recovery room and there were no complications during the procedure.Hospital care: admitted (b)(6) 2022/discharged (b)(6) 2022.There is no other patient demographic or medical history available.There is no device return.There are no photos or other images of the device provided.No additional information is available.
Additional Manufacturer Narrative
D2b: prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer.Pending investigation.There is no other information available.
Additional Manufacturer Narrative
Recall number: z-0019-2022 this follow-up report is being submitted to relay additional and/or corrected information.The product associated with the reported event is within the scope of recall z-0019-2022; however, there is insufficient information to evaluate whether the subject issue of the recall was a cause or contributor to the reported event.The following sections were updated: g1, h6 the following sections were corrected: b1, b2, g1, h6.The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear or due to inclusion of the polyethylene in the packaging recall.Additionally, a contributing factor to the reported wear may have been the result of being packaged in a non-conforming vacuum bag for more than five years.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and images and radiographs were not provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: OPTETRAK HI-FLEX TIBIAL INSERT, SZ 2, 9MM
• Common Device Name: SEE H10
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66th ct.; gainesville FL 32563
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 17198179
• Report Number: 1038671-2023-01452
• Device Sequence Number: 6798507
• Product Code: JWH
• UDI-Device Identifier: 10885862063953
• UDI-Public: 10885862063953
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K033883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/11/2020
• Device Model Number: 244-22-09
• Device Catalogue Number: 244-22-09
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/01/2023
• Supplement Date Received by Manufacturer: 12/16/2024
• Initial Report FDA Received Date: 06/26/2023
• Supplement Report FDA Received Date: 12/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2012
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0019-2022
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female